Therapeutic Instillation of Mistletoe

Brief description of study

The aim of this phase III study is to assess the efficacy of abnobaVISCUM 900 compared with
Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of
the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM
900, in particular, to compare the toxicity of the two treatments. Another secondary
objective is the treatment efficacy as measured by calculated prognosis for recurrence and
progression after 1 year, the tumor grading in case of a recurrence and by measurement of
Quality of Life.

Detailed Study Description

This is a randomized, open-label, active-controlled, prospective, multinational Phase III
confirmative study with 2 treatment groups and an adaptive design (Bauer and Khne, 1994).
The study is designed to compare the efficacy of treatment with abnobaVISCUM 900 with
Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta)
with an intermediate risk classification according to the European Association of Urology
(EAU, update 2013) and with one immediately post operative MMC 40 mg intravesical
instillation will be eligible for inclusion in the study.

The study comprises a screening period of not more than 6 weeks, a treatment period of 12
months for abnobaVISCUM 900 and MMC and a follow-up period of 12 months. Patients will be
screened within 6 weeks after the transurethral resection of the bladder (TURB) and the
immediately post operative MMC 40 mg intravesical instillation. A re-resection should be
performed before inclusion if indicated. Every patient is to provide written informed consent
before any study related procedures will be performed.